Refractive adaptation and efficacy of occlusion therapy in untreated amblyopic patients aged 12 to 40 years.

PURPOSE: Since neurophysiological and clinical trials have shown evidence for plasticity in the adult visual system, the upper age limit for amblyopia treatment is not rigid. The aim of this study was to investigate the efficacy of occlusion therapy and refractive adaptation in untreated amblyopic patients 12 to 40 years of age. METHODS: In a prospective study, all patients had full orthoptic and ophthalmic assessment including cycloplegic retinoscopy. Patients with a newly prescribed optical correction underwent an 18-week refractive adaptation. All patients were treated with occlusion for 3 h a day for 18 weeks. Acuity gain and responder rates (≥ 0.2 log units) were calculated. The rate of recurrence (visual acuity 9 months after end of the occlusion therapy; ≥ 0.2 log units) and the acuity gain after refractive adaptation were determined. Self-reported compliance to occlusion therapy was assessed. RESULTS: Median age of patients (n = 24) was 32.4 years (IQR 19.2). Best corrected visual acuity at start of occlusion therapy was 0.35 logMAR (IQR 0.5) and 0.30 (IQR 0.4) logMAR at the end of occlusion therapy, an acuity gain of 0.05 logMAR (P = 0.004). Six (25%) patients had an acuity gain of at least 0.2 logMAR units. Reading acuity was improved from 0.4 logMAR (IQR 0.4) to 0.3 logMAR (IQR 0.4) (P = 0.004). Visual acuity was stable 9 months after occlusion therapy. The acuity gain after 18 weeks of refractive adaptation was 0.05 logMAR (P = 0.238, n = 8). Acuity gain by correcting refractive errors was 0.25 logMAR (P = 0.006). Twenty-one (92%) of 24 patients achieved full recording in the calendar. Overall compliance was 17% (IQR 38). Only 5 out of 22 (23%) had acceptable compliance (≥ 50%) to occlusion therapy. Improvement of visual acuity was significantly better in patients with at least 50% compliance (P = 0.013). Compliance was worse in non-native patients than in native patients (P = 0.022). CONCLUSIONS: In adulthood, compliance to occlusion therapy is even more challenging than in children. Noncompliance is the main reason for treatment failure. Only a few patients with acceptable compliance to occlusion therapy had a small but significant improvement of visual acuity. The results suggest that some adults with amblyopia retain a degree of cortical plasticity. We found that untreated adult amblyopic patients did not wear optical correction on the amblyopic eye. The highest treatment benefit was achieved by correcting refractive errors prior to following period of refractive adaptation.

New digital methods: remodelling the harms tangent scale setting.

PURPOSE: The aim of this study is to present a feasibility study to evaluate and compare a self-constructed, digital-based tangent scale using the Harms tangent screen test for the examination of patients' strabismus angles. METHODS: The documented strabismus angles of 10 patients were measured at nine gaze-positions and compared using the Harms tangent screen test (Harms Screen) and a self-constructed digital screen test (Digital Screen). The primary outcome is the difference in the measured angles between both methods. Secondary outcomes include the duration of the examinations and the diagnostic conclusion based on the results of the measurements. RESULTS: The datasets from 10 of 13 patients were used for comparisons (median age 52 years; females 5; males 5). All measurements showed a mean of 1.77° (SD 2.95°) in horizontal deviations and 1.11° (SD 2.23°) in vertical deviations. The two methods showed differences (> 5°) in 12 cases (13.3%) for horizontal angle measurements and in four cases (4.4%) for vertical angle measurements. The median examination time was 238 s (range 60-430 s) for the Harms Screen and 150 s (range 120-600 s) for the Digital Screen tests. The diagnostic conclusions were identical for both methods. CONCLUSIONS: The feasibility of the experimental digital setup in principle is shown. Despite some deviations in the measured strabismus angles, the resulting diagnosis of the paresis was identical. The new method showed a reduction of examination time.

[Acute Diplopia: Differential Diagnosis and Treatment Options]. / Akute Doppelbilder: Differenzialdiagnose, Abklärung und Behandlungsoptionen.

Acute diplopia can be caused by harmless disorders of the optical system, but also by dangerous intracranial or intraorbital processes that lead to movement disorders of the eyes. It may therefore be difficult to decide whether further diagnostic evaluation is necessary. This article presents a short, structural overview of the most important differential diagnoses of acute diplopia and the treatment options.

Safety evaluation of "retina implant alpha IMS"--a prospective clinical trial.

BACKGROUND: To restore vision in patients with retinitis pigmentosa, several types of electronic devices have been developed to stimulate neurons at different levels along the visual pathway. Subretinal stimulation of the retina with the Retina Implant Alpha IMS (Retina Implant AG, Reutlingen, Germany) has been demonstrated to provide useful vision in daily life. Here we evaluated the safety of this device. METHODS: An interventional, prospective, multi-center, single-arm study was conducted in patients with retinitis pigmentosa with the Retina Implant Alpha IMS. The results from the first nine patients of a single center regarding safety of the device are reported. Any untoward medical occurrence related or unrelated to the tested device was documented and evaluated. RESULTS: Nine adult subjects were included in the study at the Tübingen site. Seventy-five adverse events occurred in total, and 53 affected the eye and its adnexa. Thirty-one ocular adverse events had a relationship to the implant that was classified as "certain" while 19 had a probable or possible relationship; three had no relationship to the implant. Thirty-nine ocular adverse events resolved without sequelae, two resolved with sequelae, 11 remained unresolved, and in one the status was unknown. The intensity of ocular adverse events was mild in the majority of cases (n = 45), while six were of moderate and two of severe intensity. There was no non-ocular adverse event with certain relationship to the device. One subject lost light perception (without light localization) in her study eye. CONCLUSIONS: In conclusion, this prospective study, "Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients," shows that the Retina Implant Alpha IMS is an option for restoring vision using a subretinal stimulation device with a clinically acceptable safety profile.

Artificial vision with wirelessly powered subretinal electronic implant alpha-IMS.

This study aims at substituting the essential functions of photoreceptors in patients who are blind owing to untreatable forms of hereditary retinal degenerations. A microelectronic neuroprosthetic device, powered via transdermal inductive transmission, carrying 1500 independent microphotodiode-amplifier-electrode elements on a 9 mm(2) chip, was subretinally implanted in nine blind patients. Light perception (8/9), light localization (7/9), motion detection (5/9, angular speed up to 35 deg s(-1)), grating acuity measurement (6/9, up to 3.3 cycles per degree) and visual acuity measurement with Landolt C-rings (2/9) up to Snellen visual acuity of 20/546 (corresponding to decimal 0.037° or corresponding to 1.43 logMAR (minimum angle of resolution)) were restored via the subretinal implant. Additionally, the identification, localization and discrimination of objects improved significantly (n = 8; p < 0.05 for each subtest) in repeated tests over a nine-month period. Three subjects were able to read letters spontaneously and one subject was able to read letters after training in an alternative-force choice test. Five subjects reported implant-mediated visual perceptions in daily life within a field of 15° of visual angle. Control tests were performed each time with the implant's power source switched off. These data show that subretinal implants can restore visual functions that are useful for daily life.

Visual loss without headache in children with pseudotumor cerebri and growth hormone treatment.

We report on two prepubescent girls with visual loss due to idiopathic intracranial hypertension (IIH), or pseudotumor cerebri, both treated with recombinant human growth hormone for growth failure. The interval from starting hormone therapy to diagnosis of IIH was 3 and 18 months, respectively. Both girls did not complain of headache and nausea. They were neither obese nor did they suffer from renal insufficiency. In both patients, we observed bilateral optic disc edema with visual loss and elevated cerebrospinal fluid (CSF) pressures. Other causes of IIH were excluded with neuroimaging and CSF examination. Cessation of drug administration is often sufficient for symptom resolution in cases of hormone therapy-associated IIH. However, visual field defects in one girl remained unchanged during follow-up of 8 months. In children with IIH, the spectrum of neurologic and visual manifestations might be variable and unspecific. Diagnosis and management of IIH can be difficult in the absence of headache. Blurred or double vision due to cranial nerve palsy might be the only symptom rather than complaints about reduced visual acuity. Therefore, regular clinical monitoring of visual function and fundus appearance is essential for early diagnosis, efficient management, and improvement of visual outcome in children receiving recombinant human growth hormone.

Management of strabismus with hemianopic visual field defects.

BACKGROUND: Hemianopia and strabismus leads to severe disturbance of visual orientation and diplopia under binocular conditions if the deviated eye has a normal retinal localization. SUBJECTS AND METHODS: Four cases with homonymous (two) and bitemporal (two) hemianopia and strabismus will be described with respect to binocular visual field and diplopia/confusion. All of them were recommended for strabismus surgery. Preoperatively, prism adaptation test was carried out to analyze functional results and fusional competence. In three of the four cases, strabismus surgery was successfully performed to avoid diplopia/confusion. All three patients revealed normal retinal correspondence. Furthermore, in two cases surgery led to an extension of binocular visual field; in one case with a bitemporal hemianopia and hemifield-slide phenomenon, blurred central vision and reading problems reduced significantly postoperatively. In one patient with anomalous retinal correspondence due to early childhood trauma exotropia led to an extension of the binocular visual field. In this case, strabismus surgery would have been unfavourable. RESULTS: Case 1 showed a homonymous hemianopia to the left and acquired exotropia of the right eye, leading to binocular diplopia. Case 2 with homonymous hemianopia to the right and exotropia of right eye revealed anomalous retinal correspondence after history of perinatal brain injury, resulting in absence of diplopia and enlargement of visual field to the right. Cases 3 and 4 with bitemporal hemianopia suffered from sensory disturbances caused by additional acquired strabismus. The exodeviation of the right eye in case 3 led to a restriction of binocular visual field with overlap of the nasal parts causing diplopia, whereas the esodeviation of case 4 resulted in a "gap" between the nasal parts (blind area). CONCLUSION: Depending on the extent of visual field defects and on retinal correspondence, functional consequences for binocular vision and binocular visual field should be considered prior to surgery. In normal retinal correspondence, strabismus surgery will be indicated in most cases because of diplopia. However, surgery might result in a reduction of binocular visual field. Preoperatively, it is important to map monocular and binocular visual fields, to examine retinal correspondence, and to undertake prism adaptation test to imitate the postoperative functional result and risk of double vision.

Amniotic bands as a cause of congenital anterior staphyloma.

BACKGROUND: Congenital anterior staphyloma is a rare, complex malformation syndrome of the anterior segment. Only a few reports on associated systemic malformations have been published. We herein present a rare manifestation of congenital anterior staphyloma (CAS) combined with amniotic band disruption syndrome (ABS). PATIENT AND METHODS: Shortly after birth, a massive enlargement of the left eye was observed in a female child. Furthermore, an extensive bilateral congenital cleft lip and cleft alveolar ridge with oblique facial cleft extending into the left medial canthal region, coloboma(s) of the left eyelids, extensive adhesions between lids and eye bulb, as well as circumferential grooves, clubfeet, and terminal transverse defects in both hands and feet were present. Due to severe progression of eye bulb protrusion with thinning of the sclera, enucleation of the left eye was performed at the age of 3 years in order to prevent complications including perforation of the globe and with the aim of improving cosmetic aspects. RESULTS: Histopathological examination of the enucleated eye disclosed findings typical of congenital anterior staphyloma, including massive corneal staphylomatic deformation with superficial vascularization and elapsed corneoscleral margin, destruction of Bowman's layer, absence of Descemet's layer, corneal endothelium, and angle structures. The lens was only partially formed, and had mainly dissolved. The neural retina appeared normal. The optic nerve disc revealed a pronounced excavation. Facial clefts, lid colobomas, congenital constriction bands, and amputation of distal limbs match ABS. This malformation complex develops in early pregnancy, probably prior to 35 days post conception. CONCLUSION: This is the first report on an association of these two rare complex congenital malformations, congenital anterior staphyloma and amniotic band syndrome. The anterior staphyloma was unilateral, and related to facial clefts and lid coloboma in the area adjacent to the anterior staphyloma. Furthermore, the systemic deformities are clearly due to the amniotic bands, and the timing of the development of both complex malformations seems to be similar. All findings suggest that the presence of amniotic bands is a causative factor for all observed abnormalities including anterior staphyloma.

PandAcuity in paediatrics: a novel clinical measure of visual function based on the panda illusion.

BACKGROUND/AIMS: To evaluate the PandAcuity test for visual function testing in a paediatric cohort and to examine its agreement with conventional visual acuity (VA) testing. METHODS: PandAcuity scores were determined in 152 children (77 males) aged between 3 and 15 years after VA testing (LEATM-test, E-chart, Landolt-C-rings or numbers). The PandAcuity test consisted of illusions made up from silhouettes of animals 'hidden' within zig-zag-patterns of decreasing spatial frequencies. Correlation analyses between PandAcuity score and VA were performed. RESULTS: 150 children completed the test in at least one eye, 148 in both eyes. The PandAcuity test demonstrated good test-retest reliability (intraclass correlation coefficient=0.89) between two runs. VA and PandAcuity score showed a medium to large correlation (Spearman's ρ=0.52, p<0.0001). 93% of the children's visual impairment was classified in the same range by both test types. Receiver operating characteristic analysis of predicted visual impairment showed an excellent agreement with the classification based on VA testing (AUC=0.84). CONCLUSION: The PandAcuity test is rapid, simple and well accepted, rendering it a suitable supplement for the clinical assessment of VA in children. Because of its counterintuitive application (a higher number of correctly identified images means worse VA), it can be used to cross-validate conventional acuity tests to assure children's compliance.

Surgical Management of Pre-Chiasmatic Intraorbital Optic Nerve Gliomas in Children after Loss of Visual Function-Resection from Bulbus to Chiasm.

Optic pathway gliomas in children carry significant morbidity and therapeutic challenges. For the subgroup of pre-chiasmatic gliomas, intraorbital and intradural resection is a curative option after blindness. We present a two-center cohort using different surgical approaches. A retrospective analysis was performed, including 10 children. Mean age at surgery was 6.8 years. Interval between diagnosis and surgery was 1-74 (mean 24 ± 5.5, median 10) months. Indications for surgery were exophthalmos, pain, tumor progression, or a combination. Eight patients underwent an extradural trans-orbital-roof approach to resect the intra-orbital tumor, including the optic canal part plus intradural pre-chiasmatic resection. Gross total resection was achieved in 7/8, and none had a recurrence. One residual behind the bulbus showed progression, treated by chemotherapy. In two patients, a combined supra-orbital mini-craniotomy plus orbital frame osteotomy was used for intraorbital tumor resection + intradural pre-chiasmatic dissection. In these two patients, remnants of the optic nerve within the optic canal remained stable. No patient had a chiasmatic functional affection nor permanent oculomotor deficits. In selected patients, a surgical resection from bulb to chiasm ± removal of optic canal tumor was safe without long-term sequela and with an excellent cosmetic result. Surgery normalizes exophthalmos and provides an effective tumor control.

Subretinal electronic chips allow blind patients to read letters and combine them to words.

A light-sensitive, externally powered microchip was surgically implanted subretinally near the macular region of volunteers blind from hereditary retinal dystrophy. The implant contains an array of 1500 active microphotodiodes ('chip'), each with its own amplifier and local stimulation electrode. At the implant's tip, another array of 16 wire-connected electrodes allows light-independent direct stimulation and testing of the neuron-electrode interface. Visual scenes are projected naturally through the eye's lens onto the chip under the transparent retina. The chip generates a corresponding pattern of 38 × 40 pixels, each releasing light-intensity-dependent electric stimulation pulses. Subsequently, three previously blind persons could locate bright objects on a dark table, two of whom could discern grating patterns. One of these patients was able to correctly describe and name objects like a fork or knife on a table, geometric patterns, different kinds of fruit and discern shades of grey with only 15 per cent contrast. Without a training period, the regained visual functions enabled him to localize and approach persons in a room freely and to read large letters as complete words after several years of blindness. These results demonstrate for the first time that subretinal micro-electrode arrays with 1500 photodiodes can create detailed meaningful visual perception in previously blind individuals.

Modelling the topography of absolute defects in patients exposed to the anti-epileptic drug vigabatrin and in normal subjects using automated static suprathreshold perimetry of the entire 80° visual field.

AIM: (i) To map the spatial distribution of absolute visual field loss (AL) in patients exposed to vigabatrin and to compare the findings with AL in normal individuals, and (ii) to describe the relationship between the major risk factors for absolute loss (gender, age, cumulative dose), and the severity of field loss, expressed as the number of locations with AL per eye. METHODS: Visual field plots were retrospectively reviewed from 428 individuals. Perimetry was done with the Tübingen Automated Perimeter (using a threshold-oriented, marginally supraliminal strategy, 80° eccentricity, 99 test locations). Three hundred and sixty-one individuals were ophthalmologically normal, and 67 were patients exposed to vigabatrin who had performed reliably during perimetry prior to neurosurgery for epilepsy. Two hundred and sixty-six of the 361 normals were included on the empirical basis that they manifested AL at no more than 19 stimulus locations per eye (the 74th percentile). The frequency per eye of AL at each of 99 stimulus locations was determined for the normals and patients. The effects of age, gender and cumulative dose of vigabatrin on the number of ALs per individual was assessed by an analysis of covariance. A stochastic model was developed to determine the 50% probability of AL at each location. RESULTS: Thirty-nine of the 67 vigabatrin patients exhibited at least 20 locations with AL. The number of ALs was independent of age (p = 0.7603). The frequency of AL was 14.8% in the peripheral field and 1.0% in the central field (odds ratio 16.7; 95% CI 15.0-18.6%; p < 0.0001). Those exposed to vigabatrin exhibited a frequency of 17.1% ALs, compared to 5.2% for the normal individuals (odds ratio 3.77, 95% CI 3.6-4.0%; p < 0.0001). According to the modelled data, males exhibited 20.9% (95% CI 1.3-44%; p = 0.0360) more absolute losses than did females. The number of absolute losses per person doubled with an increase in cumulative dose of vigabatrin of 936 g (95% CI 775-1181 g). CONCLUSIONS: According to this retrospective study, the spatial configuration of absolute defects attributable to vigabatrin indicates sparing of the temporal field up to approximately 60° eccentricity. Such a finding is likely to explain, at least in part, the initially asymptomatic nature of the defect. This study reconfirms a (cumulative) dose effect of vigabatrin on the extent of absolute field loss, with a greater risk for male gender.

Objective Monitoring of Spectacle Wearing Times in Adult Subjects Using the Theramon® Thermosensor.

PURPOSE: To find a reliable method to determine the wearing times of glasses in adults objectively on the basis of temperature measurements of the small-sized theramon® thermosensor device (TM) from orthodontics. Furthermore, the reliability of the determined wearing times during well and poor position of spectacles was explored. To address the previously reported lack of accuracy during higher outside temperatures, this study was conducted in midsummer and autumn. PATIENTS AND METHODS: Twenty adults wore their spectacles with three TMs attached to both inner sides and the right outer side in a period of three consecutive days. They were asked to report wearing and non-wearing times, indoor and outdoor activities and subjective perception of spectacle position as accurately as possible. To find the most reliable way to determine spectacle wearing times compared to protocolled wearing times, we applied and evaluated temperature categorizing methods and visual analysis of time logged temperatures. Percent error and percent accuracy of each method were calculated. The methods mentioned were applied and evaluated to determine poor spectacle position. RESULTS: Median percent errors of the most reliable determination methods were <10% with an accuracy between 90% and 96%. Comparing the most reliable methods, determinations on the basis of midsummer measurements (median percent error 0% to 2%, median percent accuracy 96%) were more accurate than on the basis of autumn measurements (median percent error -5% to -20%, median percent accuracy 90%). Poor spectacle position could be determined with a median percent error of 0% and a median percent accuracy of 100% by analysing the temperature measurements of TM's visually. CONCLUSION: A reliable and objective determination of spectacle wearing times is possible on the basis of TM temperature measurements in a standard clinical setting. Measurements of one inner TM seem to be sufficient to determine the wearing times and are more appealing. Poor spectacle position can be determined reliably by analysing visually the time logged temperatures. The findings of this study require further studies on larger groups of affected, amblyopic patients and children, to analyse the real impact of spectacle wearing times and poor spectacle position on visual development.

CT Assessment of Intraorbital Cable Movement of Electronic Subretinal Prosthesis in Three Different Surgical Approaches.

Purpose: Electronic retinal implants restore some visual perception in patients blind from retinitis pigmentosa. Eye movements cause mechanical stress in intraorbital power supply cables leading to cable breaks. By using computer tomography (CT) scans at the extreme positions of the four cardinal gaze directions, this study determined in vivo, which of three surgical routing techniques results in minimal bending radius variation and favors durability. Methods: Nine patients received the first-generation subretinal implant Alpha IMS (Retina Implant AG, Reutlingen, Germany) in one eye. Three techniques for intraorbital cable routing were used (straight cable route (A), parabulbar loop (B), and encircling band (C)), each in three patients. All patients underwent computer tomography of the orbital region. The bending radius of the intraorbital cable was measured with the DICOM viewer Osirix v4.1.2 (Pixmeo SARL, Bernex, Switzerland) and served as indicator for mechanical stress. Results: Average bending radius variation was 87% for method A, 11% for method B, and 16% for method C. Methods A and B (P = 0.005) and methods A and C (P = 0.007) differed significantly, while method B and C showed no statistical difference (P = 0.07). Conclusions: Compared to straight routes, arcuated cable routes significantly reduce cable movement and bending. Due to an easier surgical procedure, a parabulbar loop is the preferred method to minimize bending radius variation and prolong survival time of electronic subretinal implants. Translational Relevance: CT analysis of cable bending of implanted medical devices allows to determine which surgical routing technique favors durability in vivo.

Restriction of eye motility in patients with RETINA IMPLANT Alpha AMS.

PURPOSE: To evaluate the motility of the eye in patients with the RETINA IMPLANT Alpha AMS. METHODS: Eye motility was determined in eight gaze directions in ten blind retinitis pigmentosa patients, who had received the RETINA IMPLANT Alpha AMS, before implantation of the subretinal implant and at six time-points up to one year after. RESULTS: The analysis of eye motility showed a restriction in the upgaze and gaze to the temporal side directly after surgery in eight of the nine patients included. The degree of motility restriction decreased continuously with recovery during the observation time. One year after surgery, eye motility was still restricted in the majority of patients, especially in the upgaze to the temporal side at 20° (five of seven patients). CONCLUSION: Retinal implants with intraorbital parts (e.g. connecting cables) caused restriction in the temporal and superior viewing directions in the majority of patients. Although this restriction might be cosmetically visible, this limitation in eye motility has no effects on the monocular vision and the implant's efficacy for daily use.

Full macular translocation (FMT) versus photodynamic therapy (PDT) with verteporfin in the treatment of neovascular age-related macular degeneration: 2-year results of a prospective, controlled, randomised pilot trial (FMT-PDT).

BACKGROUND: To report the outcome of best-corrected visual acuity (BCVA), near visual acuity (NVA), contrast sensitivity (CS) and vision-related quality of life (VRQOL) in patients 2 years after undergoing photodynamic therapy (PDT) or full macular translocation (FMT) for the treatment of neovascular age-related macular degeneration (AMD). METHODS: Fifty patients with predominantly classic subfoveal choroidal neovascularisation (CNV) secondary to AMD were randomized to PDT or FMT. BCVA was determined according a standardized protocol with ETDRS charts. NVA were calculated after testing with SNAB (Swiss National Association of and for the Blind) visual acuity cards. CS was measured with Pelli-Robson charts. The 39-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25 plus supplement) was performed. Primary end points were the changes of BCVA, NVA, CS and VRQOL at 24-month examination. RESULTS: A stabilisation of BCVA (+0.3 letters) was found in the FMT group, whereas a decrease of more than 12 letters (-12.6 letters) was found in the PDT group (p = 0.052). Mean NVA improved by 7.0 letters in the FMT group and was superior to the PDT group (-9.6 letters, p = 0.036), while mean CS showed a time-dependent decrease in both treatment groups (FMT: -3.3 letters, PDT: -3.8 letters, p = 0.726). Considering the results of the VRQOL scores, the improvement of the subscales scores for general vision (p = 0.015), mental health (p = 0.028) and near activity (p = 0.020) were significantly higher in the FMT group. CONCLUSIONS: FMT can stabilise BCVA and improve NVA over a period of 2 years in patients with subfoveal classic CNV secondary to neovascular AMD, whereas a decrease of BCVA and NVA was found in the PDT group. CS did not differ between FMT and PDT. A significant increase of VRQOL scores was only found in the FMT group and not in the PDT group. FMT seems to be a therapeutic approach that can increase visual function resulting in an improvement of patient's VRQOL, but exhibits a higher number of severe complications compared to PDT.

Reading performance with low-vision aids and vision-related quality of life after macular translocation surgery in patients with age-related macular degeneration.

PURPOSE: The aim of the present study was to evaluate the power of magnification required, reading performance with low-vision aids and vision-related quality of life with reference to reading ability and ability to carry out day-to-day activities in patients after macular translocation. METHODS: This study included 15 patients who had undergone macular translocation with 360-degree peripheral retinectomy. The mean length of follow-up was 19.2 +/- 10.8 months (median 11 months). At the final examination, the impact of visual impairment on reading ability and quality of life was assessed according to a modified 9-item questionnaire in conjunction with a comprehensive clinical examination, which included assessment of best corrected visual acuity (BCVA), the magnification power required for reading, use of low-vision aids and reading speed. Patients rated the extent to which low vision restricted their ability to read and participate in other activities that affect quality of life. Responses were scored on a scale of 1.0 (optimum self-evaluation) to 5.0 (very poor). RESULTS: In the operated eye, overall mean postoperative BCVA (distance) was not significantly better than mean preoperative BCVA (0.11 +/- 0.06 and 0.15 +/- 0.08, respectively; p = 0.53). However, 53% of patients reported a subjective increase in visual function after treatment. At the final visit, the mean magnification required was x 7.7 +/- 6.7. A total of 60% of patients needed optical magnifiers for reading and in 40% of patients closed-circuit TV systems were necessary. All patients were able to read newspaper print using adapted low-vision aids at a mean reading speed of 71 +/- 40 words per minute. Mean self-reported scores were 3.2 +/- 1.1 for reading, 2.5 +/- 0.7 for day-to-day activities and 2.7 +/- 3.0 for outdoor walking and using steps or stairs. Patients' levels of dependency were significantly correlated with scores for reading (p = 0.01), day-to-day activities (p < 0.001) and outdoor walking and using steps (p = 0.001). CONCLUSIONS: The evaluation of self-reported visual function and vision-related quality of life in patients after macular translocation is necessary to obtain detailed information on treatment effects. Our results indicated improvement in patients' subjective evaluations of visual function, without significant improvement in visual acuity. The postoperative clinical benefits of treatment coincide with subjective benefits in terms of reading ability, quality of life and patient satisfaction. Our study confirms the importance and efficiency of visual rehabilitation with aids for low vision after surgery.

Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations.

Purpose: We assessed the safety and efficacy of a technically advanced subretinal electronic implant, RETINA IMPLANT Alpha AMS, in end stage retinal degeneration in an interim analysis of two ongoing prospective clinical trials. The purpose of this article is to describe the interim functional results (efficacy). Methods: The subretinal visual prosthesis RETINA IMPLANT Alpha AMS (Retina Implant AG, Reutlingen, Germany) was implanted in 15 blind patients with hereditary retinal degenerations at four study sites with a follow-up period of 12 months (www.clinicaltrials.gov NCT01024803 and NCT02720640). Functional outcome measures included (1) screen-based standardized 2- or 4-alternative forced-choice (AFC) tests of light perception, light localization, grating detection (basic grating acuity (BaGA) test), and Landolt C-rings; (2) gray level discrimination; (3) performance during activities of daily living (ADL-table tasks). Results: Implant-mediated light perception was observed in 13/15 patients. During the observation period implant mediated localization of visual targets was possible in 13/15 patients. Correct grating detection was achieved for spatial frequencies of 0.1 cpd (cycles per degree) in 4/15; 0.33 cpd in 3/15; 0.66 cpd in 2/15; 1.0 cpd in 2/15 and 3.3 cpd in 1/15 patients. In two patients visual acuity (VA) assessed with Landolt C- rings was 20/546 and 20/1111. Of 6 possible gray levels on average 4.6 ± 0.8 (mean ± SD, n = 10) were discerned. Improvements (power ON vs. OFF) of ADL table tasks were measured in 13/15 patients. Overall, results were stable during the observation period. Serious adverse events (SAEs) were reported in 4 patients: 2 movements of the implant, readjusted in a second surgery; 4 conjunctival erosion/dehiscence, successfully treated; 1 pain event around the coil, successfully treated; 1 partial reduction of silicone oil tamponade leading to distorted vision (silicon oil successfully refilled). The majority of adverse events (AEs) were transient and mostly of mild to moderate intensity. Conclusions: Psychophysical and subjective data show that RETINA IMPLANT Alpha AMS is reliable, well tolerated and can restore limited visual functions in blind patients with degenerations of the outer retina. Compared with the previous implant Alpha IMS, longevity of the new implant Alpha AMS has been considerably improved. Alpha AMS has meanwhile been certified as a commercially available medical device, reimbursed in Germany by the public health system.

Limitations of the TheraMon® -microsensor in monitoring occlusion therapy.

PURPOSE: A proof of principle study showed that the TheraMon® -microsensor can reliably measure wearing times of glasses and occlusion patches while having no discomfort for the bearer. The goal of this study was to identify specific temperature profiles in a larger patient group wearing the microsensor with an occlusion patch on the eye, the forehead or in the trouser pocket. METHODS: Temperature measurements with microsensors were performed at the orbital rim of the eye, at the forehead and in a trousers pocket of 20 healthy adults. The temperature measurements were analysed comparing the three locations using a repeated-measures anova with a 0.050 two-sided significance level. RESULTS: There was no significant temperature difference in wearing the microsensors at the orbital rim compared to forehead (p = 0.507). A significant difference could be detected if the microsensors had been in trousers pockets as compared to being positioned at orbital rim/forehead (p = 0.001). The study participants reported easy handling and comfortable wearing. CONCLUSION: This study demonstrates for the first time that TheraMon® -microsensors are fully operational in monitoring occlusion therapy in a larger group of patients (20 adult study participants). Because of the microsensor's ease of handling further studies in a larger group of children is recommended.